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FDA 510(k)

TOTAL PROTEIN URINE/CSF GEN.3

K-Number: K071239 · 2007-09-14

ApplicantRoche Diagnostics
Decision Date2007-09-14
Product CodeJGQ
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

TOTAL PROTEIN URINE/CSF GEN.3 is the device name listed in this FDA 510(k) record. The listed applicant is Roche Diagnostics. It received FDA 510(k) clearance on 2007-09-14 under 510(k) number K071239. The device is classified under product code JGQ. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the TOTAL PROTEIN URINE/CSF GEN.3?

TOTAL PROTEIN URINE/CSF GEN.3 is a medical device that received FDA 510(k) clearance on 2007-09-14. The listed applicant is Roche Diagnostics. The 510(k) number is K071239.

When did TOTAL PROTEIN URINE/CSF GEN.3 receive FDA 510(k) clearance?

TOTAL PROTEIN URINE/CSF GEN.3 received FDA 510(k) clearance on 2007-09-14, under 510(k) number K071239.

Who is the listed applicant for TOTAL PROTEIN URINE/CSF GEN.3?

The FDA 510(k) record lists Roche Diagnostics as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for TOTAL PROTEIN URINE/CSF GEN.3?

The FDA product code for TOTAL PROTEIN URINE/CSF GEN.3 is JGQ.

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Related Devices (Code: JGQ)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K131051HITACHI S TEST REAGENT CARTRIDGE TOTAL PROTEIN (TP) AND ALBUMIN (ALB)Hitachi Chemical Diagnostics, Inc.K072638ROCHE/HITACHI URINARY/CSF PROTEIN WITH MODEL(S) CAT #11877801Roche Diagnostics Corp.K981295UPROAbbott LaboratoriesK981682UPROAbbott LaboratoriesK925794TRACE MICROPROTEIN REAGENTTrace America, Inc.K913615URINARY/CSF PROTEINBoehringer Mannheim Corp.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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